Friday, October 26, 2007

Fail to Warn about Anything - Liabilty for Everything?

We’ve had the misfortune to encounter recently failure to warn claims that we think should be dismissed (well, we think all claims against our clients should be dismissed – but these especially) because they just don’t make any sense. The claims we’re ticked off about at the moment involve a disconnect between the allegations and the facts. Specifically, because they involve warnings about kinds of injuries that the plaintiffs themselves don’t even claim to have.

Yeah, that’s right – some plaintiffs have the gall to say that our clients’ warnings about, say, gallstones (that’s a good one), are “inadequate,” even though they’ve never suffered from a gallstone in their lives.

We see this mostly in the context of mass torts, where the name of the game is to try to overwhelm defendants with as many claims as possible, even if there’s no basis for them. There’s a flurry of advertising trying to scare people about Drug X, and the hotlines collect claims by people who don’t have the condition that originally motivated the litigation. We’ve also encountered this type of warning claim in one-off cases, mostly where something goes south (usually an expert, but sometimes a treater) on what was originally thought to be the main claim – think of a claim where the plaintiff starts off claiming overdose, but then neither the records not the experts can support that.

In either event, what we wind up with are plaintiffs who claim something like this: “So what if I didn’t actually have a stroke? You still didn’t warn about the risk of stroke. If you’d told the truth about strokes I’d have been so scared I wouldn’t have bought your product at all, no matter what my prescriber told me, and I wouldn’t have been gotten kidney failure…. Oh, yeah, and by the way, because you didn’t warn about stroke, it doesn’t matter that you did warn about the risk of kidney failure in 13 different ways.”

Needless to say, to us this kind of claim is bogus. For one thing, the argument stretches the fabric of causation too thin. The act that the plaintiff claims would have been deterred is the purchase of the product in the first place, not an improper use of the product. Well, the purchase of an FDA-approved prescription medical product is not, in and of itself, the kind of act the law of torts should be seeking to deter. What product liability law is supposed to be about is preventing injuries from defective products – and if the manufacturer warned of the only injury that actually happened, then there’s no defect.

In our opinion.

The other really obnoxious thing about this kind of claim is that it dramatically expands both liability and the scope of discovery. It expands liability because an inadequate warning about anything all of a sudden turns into liability for everything – even risks about which the defendant actually give an adequate warning. It expands discovery because any purportedly inadequate warning about any conceivable risk suddenly becomes relevant in every case, because the plaintiff can just say “if you’d warned about that, I wouldn’t have followed my doctor’s orders and used that product.”

Anyway, the good news is that this type of claim has been recognized for what it is and has generally been rejected. There’s a really smart professor, Dan Dobbs, who wrote his own book on torts (before Bexis did), and he says these claims are beyond the pale. “[T]he injury suffered [by a plaintiff] must be within the class of injury that the warning requirement was meant to avoid.” Dan B. Dobbs, The Law of Torts, at 1018 (2001). He uses an asbestos example to make his point, but the rationale is just as the same for a claim that a stroke warning could be relevant where the plaintiff suffered from kidney failure:

For example, the plaintiff, if properly warned that asbestos might cause cancer, might have ceased to work around asbestos. . . . But the failure to provide such warning would not result in liability if the plaintiff, not being warned, kept her job and lost a hand in a job-related machine accident. In that example, failure to warn would be a cause in fact. . .but it is not a proximate legal cause. It is not, in other words, within the risk that a warning was designed to avoid.

Id.

There are also decisions in our own area of expertise that refuse to allow a plaintiff to recover for injury “A” with an allegation that the defendant failed to warn solely about injury “B.” Drug warnings relating to injuries that a plaintiff did not suffer are simply irrelevant. For example, a vaccine recipient who suffered Guillain-Barre syndrome couldn’t raise allegations of inadequate warnings concerning “other risks such as serum sickness or myelitis”:

The question of the adequacy of the warnings must be confined to consideration of whether the warnings were sufficient to inform the plaintiff of the risk of the particular condition or disease which allegedly caused his injury. . . . [A] determination that warnings were inadequate with respect to some other condition does not bear on our conclusion that [plaintiff] was adequately informed of the risk of severe allergic reaction to the swine flu vaccine.

Mills v. United States, 764 F.2d 373, 379 (5th Cir. 1985).

For some reason vaccine cases first seemed to attract this sort of claim. In Novak v. United States, 865 F.2d 718, 726 (6th Cir. 1989), the court likewise ruled that “the district court erred in finding the warning inadequate, negligent, and insufficient because it did not specifically caution those who may have experienced ‘viral encephalitis’” where “[i]t was not proven that [plaintiff] had actually suffered from viral encephalitis.” In Novak it must have been rather obvious that the plaintiff was alleging remote warning claims to avoid having to prove that he suffered from the correct injury.

The New York Court of Appeals (the highest court in that state) confronted a similar claim in Martin v. Hacker, 628 N.E.2d 1308 (N.Y. 1993). Martin was a classic example of the “type two” case we mentioned earlier. The plaintiff alleged inadequate warnings because there wasn’t a contraindication (something telling doctors don’t use the product at all in a particular situation) due to an supposedly increased risk of suicide in “depressed” patients. The plaintiff’s proof failed – because nobody could establish that the decedent was depressed. The plaintiff tried to go ahead with the claim anyway, but the court said no way. It held, “we are not concerned with the adequacy of the Contraindications section” because the decedent “had no history of” depression. Id. at 1313.

A classic “type one” mass tort example of the “you failed to warn about something else” claim arose in In re Rezulin Products Liability Litigation, 331 F. Supp.2d 196 (S.D.N.Y. 2004). The rap against Rezulin has been that it causes liver problems, but in their rush to solicit all the claims they could, the plaintiffs’ attorneys ended up with a number of claims that did not involve liver injury at all. Since they couldn’t be bothered proving anything about those plaintiffs’ actual injuries, the MDL counsel tried to go with the liver injury warning case they’d developed even where there was nothing wrong with these plaintiffs’ livers – alleging instead that these plaintiffs wouldn’t have used Rezulin at all if there’d been a better lever warning.

Plaintiffs’ final contention is that the alleged failure adequately to warn of the risk of liver damage was causally connected to their injuries, even assuming that they sustained no liver injury, because an adequate disclosure of the hepatic risks would have deterred physicians from prescribing the drug although such potential side effects as headaches and nausea were insufficiently grave to have done so. . . .

Id. at 201. The court tossed those claims out on their proverbial ear. This “argument fail[ed]” for several reasons: (1) the expert who supposedly supported the claim didn’t treat any of the plaintiffs and couldn’t say what the actual treaters would have done; (2) plaintiffs couldn’t prove that the nondisclosed risk “was sufficiently high that it would have changed the treating physician’s decision,” and (3) because the risk wasn’t the one the plaintiffs suffered, “the evidence upon which plaintiffs rely is insufficient to justify an inference that the physicians who treated these plaintiffs would not have prescribed the drug.” Id. Moreover, as to the injuries that these plaintiffs did have, “the PDR specifically warned of the[m]” so the warnings that mattered were adequate as a matter of law. Id. at 202.

In Pennsylvania, breast implant plaintiffs sued, not only manufacturers, but physicians – presumably because they wanted to defeat diversity jurisdiction. They alleged the same sort of claim, only couched in informed consent rather than product liability, that the prescribiing doctors failed to discuss certain risks (gel bleed, infection, autoimmune diseases) when the only thing they suffered from was something else (capsular contracture). The court held that this kind of warning liabilty was too broad to be permitted:

If I accept plaintiffs’ argument, the law will be permitting recovery for a risk that the plaintiff assumed because the plaintiff might have made a different decision as a result of knowing of other risks for which the plaintiff did not experience any harm.

In re Silicone Breast Implant Litigation, 64 D. & C. 4th 21, 25-26 (C.P. Allegheny Co. 2003). To allow liability based upon undisclosed risks that never happened “would have a reach that extends far beyond the purposes for the doctrine.” Id. at 26.

There are a number of other cases that say more or less the same thing. Eck v. Parke, Davis & Co., 256 F.3d 1013, 1020 (10th Cir. 2001) (failure to warn of concomitant use of two drugs noncausal where prescriber did not prescribe concomitantly); King v. Danek Medical, Inc., 37 S.W.3d 429, 446-47 (Tenn. App. 2000) (“theoretical possibility that some pedicle screw devices. . .can cause various bone problems, without proof that it occurred to these plaintiffs. . ., cannot defeat summary judgment”); Peterson v. Parke Davis & Co., 705 P.2d 1001, 1004 (Colo. App. 1985) (“the request for an instruction that [defendant] had a duty to warn of all known dangers was properly denied. In a failure to warn case, the plaintiff has the burden of proving that the manufacturer gave inadequate warning of the danger which caused the injury”); In re Norplant Contraceptive Products Liability Litigation, 1997 WL 81094, at *1 (E.D. Tex. Feb. 21, 1997) (“[W]hether the Norplant physician warnings were not adequate with respect to an injury not alleged is not relevant to whether physicians were adequately warned of [p]laintiffs’ alleged injuries”).

We think these cases are rightly decided. In product liability, failure to warn is truly the last refuge of the scoundrel, for a lot of reasons, such as not having to spend the money to get engineering experts to come up with alternative designs. There’s a difference between bare “but for” causation and the kind of legal cause necessary before the law will impose liability. It’s what lawyers call “substantial factor”:

The word “substantial” is used to denote the fact that the defendant’s conduct has such an affect in producing the harm as to lead reasonable men to regard it as a cause, using that word in the popular sense, in which there always lurks the idea of responsibility, rather than in the so-called ‘philosophic sense,’ which includes every one of the great number of events without which any happening would not have occurred. Each of these events is a cause in the so-called “philosophic sense,” yet the effect of many of them is so insignificant that no ordinary mind would think of them as causes.

Restatement (Second) of Torts §431, comment a (1965).

A claim that a failure to warn about one thing would have fortuitously prevented an entirely separate injury (that may well have been adequately warned about) by causing the plaintiff’s prescribing physician not to prescribe the product at all or the plaintiff to disobey doctor’s orders is simply too tenuous a causal link. In the words of the Restatement, that kind of thing is merely “one of the great number of events without which any happening would not have occurred,” and that’s not enough.

1 comment:

Anonymous
said...

Should it not be the responsibility of the pharmaceutical company which manufactured the drug to warn the patient taking the drug the side effects of he drug. If not, who should warn the public? To say that timely warning is not necessary would take away the safety of people allowing pharmaceutical companies to manufacturedrugs irresponsibly

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This blog contains the personal views of the Blogging Team identified below (and of any authors of guest posts) concerning various topics that arise in the defense of pharmaceutical and medical device product liability litigation. Please read the DISCLAIMER about the nature of this blog, and understand that you are accepting its terms, before reading any of the posts here.

Blogging Team

James M. Beck is Counsel resident in the Philadelphia office of Reed Smith. He is the author of, among other things, Drug and Medical Device Product Liability Handbook (2004) (with Anthony Vale). he wrote the seminal law review article on off-label use cited by the Supreme Court in Buckman v. Plaintiffs Legal Committee. He has written more amicus briefs for the Product Liability Advisory Council than anyone else in the history of the organization, and in 2011 won PLAC's highest honor, the John P. Raleigh award. He can be reached at jmbeck@reedsmith.com.

Stephen McConnell has authored articles and chapters on product liability (though nothing as snappy or authoritative as Beck's book) and has tried drug and device cases that managed to evade the pretrial gauntlet. He is a partner in the Philadelphia office of Reed Smith and can be reached at smcconnell@reedsmith.com.

Michelle Hart Yeary is a seasoned products liability litigator who focuses on attempting to bring order to the chaos that is mass torts, concentrating on the practicalities and realities of defending coordinated and multidistrict litigation. She is counsel in the Princeton office of Dechert LLP and can be reached at michelle.yeary@dechert.com.

John J. Sullivan is a products liability and commercial litigator, having authored articles on mass torts and securities litigation and presented on trial advocacy. He is experienced in mass tort litigation, with a particular emphasis on scientific and regulatory issues, as well as having experience in complex commercial, securities class action and corporate governance litigation. He is a partner in the downtown Manhattan and New Jersey offices of Cozen O'Connor and can be reached at jsullivan@cozen.com.

Eric L. Alexander is a partner in Reed Smith’s Washington office. He has spent almost his entire career representing drug and device companies in product liability litigation from discovery through motions, trials, and appeals, usually on the right side of the v. He is particularly interested in medical and proximate cause and the intersection of actual regulatory requirements and the conduct that plaintiffs allege was bad, which covers quite a bit. He can be reached at ealexander@reedsmith.com.

Steven J. Boranian is a partner in Reed Smith’s San Francisco office, where he focuses his practice on representing drug and medical device companies in product liability and other kinds of litigation. He has handled drug and device matters from pre-litigation demands to appeals and all points in between, with particular interests in “mass” proceedings and class actions, to the extent the latter should ever be allowed in the drug and medical device context. He can be reached at sboranian@reedsmith.com.

Rachel B. Weil is counsel in Reed Smith’s Philadelphia office. Except for a brief, misguided trip to the “dark side,” Rachel has spent her whole career defending drug and device manufacturers in product liability litigation and in government actions arising from such litigation. While she laments the single-plaintiff drug cases of her youth, she loves nothing better than a good mass tort. She can be reached at rweil@reedsmith.com
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